EMEA-002765-PIP01-19 - paediatric investigation plan

ribociclib succinate

Key facts

• Invented name:
  Kisqali
• Active Substance:
  ribociclib succinate
• Therapeutic area:
  Oncology
• Decision number:
  P/0218/2020
• PIP number:
  EMEA-002765-PIP01-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of breast cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/06/2020

Decision

P/0218/2020: EMA decision of 17 June 2020 on the granting of a product specific waiver for ribociclib (succinate) (Kisqali), (EMEA-002765-PIP01-19)

AdoptedReference Number: EMA/258042/2020